High Intensity Interval Training in Chronic Stroke (HIT)

April 8, 2017 updated by: Brett Kissela, University of Cincinnati
The objective of this study was to compare the effectiveness of high intensity interval training (HIT) and traditional aerobic training for persons with stroke.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants were randomized to either HIT or traditional aerobic training; each 25 minutes, 3 times per week for 4 weeks. Outcomes were measured before and after training by a blinded rater.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1) age 35-90 years
  • 2) unilateral stroke experienced >6 months prior to enrollment
  • 3) able to walk 10m overground with assistive devices as needed and no physical assistance
  • 4) able to walk 3 minutes on the treadmill at >.13m/s (0.3mph) with no aerobic exercise contraindications
  • 5) stable cardiovascular condition (American Heart Association class B, allowing for aerobic capacity <6 metabolic equivalents)
  • 6) discharged from formal rehabilitation

Exclusion Criteria:

  • 1) significant resting ECG abnormalities
  • 2) evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test
  • 3) hospitalization for cardiac or pulmonary disease within 3 months
  • 4) pacemaker or implanted defibrillator
  • 5) lower extremity claudication
  • 6) unable to communicate with investigators or correctly answer consent comprehension questions
  • 7) severe lower extremity spasticity (Ashworth >2)
  • 8) lower extremity weight bearing pain >4/10 on visual analogue scale

For the transcranial magnetic stimulation substudy, additional exclusions will also be applied. These include large cerebral infarcts or other structural defects with the potential to increase seizure risk, uncontrolled seizures, metal implants and previous craniotomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-intensity interval training (HIT)
Treadmill exercise using bursts of concentrated effort alternated with recovery periods
Other: High-intensity interval training (HIT)
Treadmill exercise using bursts of concentrated effort alternated with recovery periods
Active Comparator: Traditional aerobic training
Moderate intensity continuous aerobic exercise on a treadmill
Other: Traditional Aerobic Training
Moderate intensity continuous aerobic exercise on a treadmill

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Peak Aerobic Capacity (VO2-peak)
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Change in Gait Velocity (10 Meter Walk Test)
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Change in 6-Minute Walk Test
Time Frame: Baseline and 4 weeks
distance walked in 6 minutes
Baseline and 4 weeks
Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)
Time Frame: Baseline and 4 weeks
mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter
Baseline and 4 weeks
Change in Fastest Treadmill Speed (Steep Ramp Test)
Time Frame: Baseline and 4 weeks
fastest safe treadmill walking speed
Baseline and 4 weeks
Change in Fractional Utilization
Time Frame: Baseline and 4 weeks
Metabolic cost of gait as a percentage of aerobic capacity
Baseline and 4 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Self-Efficacy and Outcome Expectations for Exercise Scale
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Change in Montreal Cognitive Assessment
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks
Time Frame: Baseline and 4 weeks
3D motion capture and force plates
Baseline and 4 weeks
Change in Gait Kinematics/Kinetics From Baseline to Post Session 1
Time Frame: Baseline and after session 1
3D motion capture and force plates
Baseline and after session 1
Change in Gait Kinematics/Kinetics During Session 1
Time Frame: During session 1
3D motion capture and force plates
During session 1
Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks
Time Frame: Baseline and 4 weeks
Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition
Baseline and 4 weeks
Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2
Time Frame: Before and after training session 2
Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition
Before and after training session 2
Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12
Time Frame: Before and after training session 12
Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition
Before and after training session 12
Change in Daily Physical Activity (Activity Monitor)
Time Frame: Baseline and 4 weeks
Baseline and 4 weeks
Change in Stroke Impact Scale
Time Frame: Baseline and 4 weeks
Cognition Domain Score of Stroke Impact Scale. Scores range from 0 to 100 (higher is better) and represent a sum of scores from multiple questions related to cognition.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cincinnati

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital Medical Center, Cincinnati
American Physical Therapy Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brett Kissela, MD, University of Cincinnati
  • Principal Investigator: Kari Dunning, PhD, PT, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIT in chronic stroke

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings